HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO™ (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018 ----------------------------INDICATIONS AND USAGE--------------------------- SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. (12.1, 14) If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. ----------------------DOSAGE AND ADMINISTRATION----------------------- ? Adults and pediatric patients ages 12 years and older: one tablet (containing tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one tablet (containing ivacaftor 150 mg) in the evening, approximately 12 hours apart. SYMDEKO should be taken with fat-containing food. (2.1, 12.3) ? Reduce dose in patients with moderate and severe hepatic impairment. (2.2, 8.6, 12.3) ? Reduce dose when co-administered with drugs that are moderate or strong CYP3A inhibitors. (2.3, 7.2, 12.3) ---------------------DOSAGE FORMS AND STRENGTHS---------------- Tablets: ? SYMDEKO is co-packaged as tezacaftor 100 mg/ivacaftor 150 mg fixed dose combination tablets and ivacaftor 150 mg tablets. (3) -------------------------------CONTRAINDICATIONS-------------------------- ? None. (4)